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Stimulator, Auditory, Evoked Response
FDA product code GWJ · Class 2 · Neurology
1,014
Registered devices
119
Adverse events
4
Recalls
76
510(k) clearances
Devices with this code
NA — MEDTRONIC XOMED, INC.Sierra Summit — CADWELL INDUSTRIES, INC.Integrity Insert Earphones — Vivosonic IncNA — MEDTRONIC XOMED, INC.QScreen Set — PATH medical GmbHGN Otometrics A/S — Natus Medical Denmark ApSSanibel Supply — Interacoustics A/SOtoport/Otocheck Mini Printer — OTODYNAMICS LIMITEDCascade Elite — CADWELL INDUSTRIES, INC.IOMAX Extender Pod — CADWELL INDUSTRIES, INC.Otoport - Screener with ABR — OTODYNAMICS LIMITEDInsert Earphone PIEP — PATH medical GmbHCARESCAPE B850 — GE Healthcare Finland OyAccuScreen — Natus Medical Denmark ApSSierra Summit — CADWELL INDUSTRIES, INC.Sierra Wave — CADWELL INDUSTRIES, INC.GN Otometrics A/S — Natus Medical Denmark ApSNIM-ECLIPSE® — MEDTRONIC XOMED, INC.Power-LAN Connection Box — EB NEURO SPADPOAE probe tips — OTODYNAMICS LIMITEDGN Otometrics A/S — Natus Medical Denmark ApSOtoport Pro AABR instrument — OTODYNAMICS LIMITEDOtoport Pro Docking Station — OTODYNAMICS LIMITEDSentiero Desktop AuDX PRO FLEX — PATH medical GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE a |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) prema |
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